A Prosthetic Foot Test-Drive Strategy for Improving Stability in Veterans With Leg Amputations
Recruiting now · Not applicable
Conditions studied: Amputation
In brief
Objective/Hypotheses and Specific Aims: The first aim of this proposal is to determine the effects of commercial prosthetic feet of varying stiffness on stability and falls-related outcomes in Veterans with TTA. The second aim is to determine whether a PFE can be used to predict stability and balance-confidence outcomes with corresponding commercial prosthetic feet. The third and final aim is to determine whether a brief trial of commercial prosthetic feet can predict longer-term stability and balance-confidence outcomes in Veterans with TTA. Study Design: The investigators will use a participant blinded cross-over study with repeated measurements in Veterans and Service members with TTA. Up to 50 participants will be enrolled at each of the two study sites VA Puget Sound and VA Minneapolis. Participants will complete up to 6 visits. After an initial assessment visit, participants will be assigned to the 'high' or 'low' mobility group, and then during visit 2 they will be randomized to use the PFE in three foot modes or the three corresponding actual (commercially available) feet during walking tests on difference surfaces in the laboratory (cross-slopes, inclines, even, and uneven ground). During visit 3 participants will repeat the procedures in the other condition (e.g., PFE if visit 2 included actual feet testing). At the end of visit 3 participants will be fit with one of the actual feet and wear it at home and in the community for approximately one week. At visit 4 participants will be fit with the next actual foot and repeat the 1 week use window. The same process will be followed for the final foot at visit 5, and the study foot will be returned at visit 6.
Key facts
- Study ID
- NCT05473065
- Run by
- Seattle Institute for Biomedical and Clinical Research
- People needed
- 100
- Starts
- 2024-03-01
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2025-09-08
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- has a unilateral (one leg) transtibial (below-knee) amputation
- has used a prosthetic limb for walking for at least six months
- has a comfortably fitting prosthetic socket
- has a removable prosthetic foot attachment (i.e., is not rigidly attached to the back of the socket) so it can be used with study prosthetic feet
- be able to walk with a prosthetic limb sufficiently to participate in the experiment walking trials
You may not qualify if…
- contralateral limb or upper limb amputation that would interfere with completion of study activities
- are unable to use more than one of the test feet for any reason (e.g., excessively long residual limb that is not compatible with wearing study prosthetic feet)
- unable to walk under the minimal necessary study walking conditions in order to complete the study procedures without undo stress
- current surgical, neurological, rheumatologic, or lower limb musculoskeletal problem that significantly impairs ambulation (e.g., current ulcer, terminal illness)
- weight greater than 263lbs.
- inadequate cognitive or language function to consent to participate
- currently incarcerated
- impaired decision-making ability or the use of a legally authorized representative
Where it is running
- VA Puget Sound Health Care System — Seattle, Washington, United States (enrolling)
- Minneapolis VA Medical Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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